1. A rational Medicines Policy for Europe Danielle Bardelay Medicines in Europe Forum HAI Seminar - The Hague 18 November2004

2. Therapeutic advance ? « The practices of the pharmaceutical industry and regulators blurr the distinction between genuine therapeutic advance and mere innovation » –(ISDB - International Society of Drug Bulletins - Declaration on therapeutic advance in the use of medicines Paris 15 -16 November 2001) -

3. A clear difference between: newly marketed substance, or indication, or formulation, etc. industrial innovation (chemistry, biotechnology) therapeutic advance : « a new treatment that benefits the patient when compared to existing options » –(ISDB Declaration) -

4. 23 years of independent rating of 2871 new drugs (by La revue Prescrire) Bravo : 0,24 % A real advance : 2,68 % Offers an advantage : 7,56 % Possibly helpful : 15,85 % Nothing new : 66,63 % Not acceptable : 2,79 % Judgement reserved : 4,25 %

5. Convergent analysis US National Institute for Health Care Management : 76 % of new drugs classified as non-priority for review by the FDA Canadian Patented Medicine Prices Review Board : just 6 % breakthrough medications The content of reviews on new drugs published by La revue Prescrire and the Swedish Medical Product Agency bulletin is broadly similar (Int J Risk & Safety in Medicine 2004)

6. Concerns with cost prices of 12 new anticancer drugs approved by the European medicines Agency between 1995 and 2000 (Garattini S British Medical Journal 2002) : –3 to 350 times as much as reference drug –for « few or non substantial advantages over existing preparations »

7. Concerns with safety triazolam story fenfluramin - phentermin story amineptine story cerivastatin story rofecoxib story (+ valdecoxib, parecoxib, etc.) SSRI antidepressants story next ?… new antidiabetics, or anticoagulants, or immunosuppressants, or Ritaline°... ?

8. Dramatic lack of : adequate comparative evaluation : – no idea of the added therapeutic value transparent pharmacovigilance : – no real prevention of side effects prevention of medication errors : – no proper use of drugs primary prevention to limit risk factors : – little success in disease limitation

9. Priority to relevant evaluation pre-marketing evaluation –because post-marketing means uncertain (FDA statistics on fulfilment of conditions) comparative evaluation –versus best available option (at right dose, etc.) (WHO report on Priority Medicines) focused on benefits and on risks

10. Areas for priorities rare diseases : the Orphan Drug Regulation is already here. A survey on fairness of its implementation is needed. pediatric diseases : the coming Regulation may help for small groups of children. But other groups already have too many drugs. elderly, pregnant women, patients with renal failure, etc. require specific evaluation

11. Areas for priorities (continued) cancer, multiple sclerosis, Alzheimer disease, severe viral infections : their severity is not an excuse for poor evaluation. acute and chronic pain : also not an excuse for the extremely poor current evaluation. groups of old useful drugs : require additional evaluation (for ex : on doses) but companies are not interested (for ex : diuretics). drug utilization studies.

12. Priority to pharmacovigilance transparency of agencies, access to data, visibility of decision making attention paid to patients direct reporting visible implementation of decisions (warnings, cautions, etc.)

13. Priority to prevention of medication errors not all errors are linked to dangerous professional practices safer packaging, relevant and understandable patient leaflets are needed (Council of Europe working group) promotional biased patient « information » pushed by companies is not needed

14. Priority to primary prevention diabetes, obesity, cardiovascular diseases, lung (and other) cancers in Europe will not disappear with help of more new drugs nutritional, environmental, infectious, primary prevention is the priority (WHO Strategy 2004) cost of prevention campaigns and cost of drug reimbursement should be compared

15. Restoring confidence more and more patients and health professionals consider drug agencies and health authorities as unreliable the Dutch Presidency initiative is an opportunity for restoring confidence : –choice of research priorities –attribution of financial support –follow up of supported research – should be fully transparent

16. Medicines in Europe Forum will closely follow up this initiative on priority medicines hopes that patients needs will be seriously considered hopes that neglected diseases more frequent outside Europe will really be considered and thanks HAI warmly for this seminar which raises patient oriented priorities.